Artificial Intelligence Combined With 3D-Preformed Chest Wall Defection Reconstruction System in Chest Wall Tumor Surgery

NCT06978075 | Not Yet Recruiting DMC

• 1 other identifier: 20240910
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chest wall tumors should be completely resection as much as possible while malignant chest wall tumors should be extensively resection. If not completely resection, it will recur in the short time and affect the patient's survival. At present, the surgical resection range mainly relies on preoperative imaging examination and the experience of the surgeon. It lacks precise guidance. This can easily lead to incomplete resection. In addition, the reconstruction materials required for reconstruct the excised chest wall defection are often generated in a standardized manner, lacking intraoperative adjustability. To address this clinical issue, we plan to carry out the research on the application of artificial Intelligence (AI) assisted chest wall tumor resection combined with personalized 3D preformed chest wall defection reconstruction system in chest wall tumor surgery.

Conditions

Chest Wall Tumor; Reconstruction Surgery

Keywords

chest wall tumor resection and reconstrucion

Outcome Measures

Primary Outcomes (1)

• the tumor status of surgical margin

  Visible tumor residue with naked eye, tumor cells visible under microscope, no tumor cells observed under microscope

  3 year

Secondary Outcomes (1)

• Stability after chest wall reconstruction

  3 year

Study Arms (1)

chest wall tumor

EXPERIMENTAL

Device: Chest wall tumor resection by the artificial intelgent assistent

Interventions

Chest wall tumor resection by the artificial intelgent assistent DEVICE

we plan to carry out of the research on the application of artificial intelligence (AI) assisted chest wall tumor research combined with a personalized 3D preformed chest wall defect reconstruction system in chest wall tumor surgery. Data will be imported into a computer to draw a 3D model of the tumor and construct an ideal resection range to ensuring sufficient surgical margins while avoiding damage to important nerve and vascular tissues in the chest. Preformed titanium plates will be prepared based on the calculated resection range and the titanium plates will be detachable assembly components through screws, which can be adjusted at any time according to the surgical situation.

chest wall tumor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, male or female not limited
• Anesthesia ASA score I-II
• Malignant tumor of soft tissue in the chest
• Malignant tumors of ribs, rib cartilage, and sternum
• Tumors with uncertain or unknown properties of ribs, rib cartilage, and sternum
• Giant benign tumors of ribs, rib cartilage, and sternum
• The preoperative examination results indicate that the tumor has not undergone distant metastasis
• Willing to participate in the research and sign the informed consent form

You may not qualify if:

• Patients with distant metastasis detected during preoperative examination
• Inoperable tumor
• During the examination, it was discovered that the patient had another type of malignant tumor present
• ECOG 4
• Suffering from active or chronic fungal/bacterial/viral infections
• History of allergy to anesthesia related drugs
• Heart and lung dysfunction, liver and kidney dysfunction, inability to tolerate surgery
• Patients with mental disorders who are unable to cooperate with treatment

Sponsors & Collaborators

• Wu Weiming: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shanghai Jiao Tong University Affiliated Sixth People's Hospital of medicine

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 18, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share